Classifications

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  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
  • A61B5/14542—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring blood gases
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  • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
• • A—HUMAN NECESSITIES
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  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
  • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
  • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
  • A61B5/14552—Details of sensors specially adapted therefor
• • A—HUMAN NECESSITIES
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  • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
  • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
  • A61B5/14553—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases specially adapted for cerebral tissue
• • A—HUMAN NECESSITIES
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  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
  • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
  • A61B5/683—Means for maintaining contact with the body
  • A61B5/6832—Means for maintaining contact with the body using adhesives
  • A61B5/6833—Adhesive patches
• • A—HUMAN NECESSITIES
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  • A61B5/7271—Specific aspects of physiological measurement analysis
  • A61B5/7275—Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
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  • A61B5/74—Details of notification to user or communication with user or patient; User input means
  • A61B5/742—Details of notification to user or communication with user or patient; User input means using visual displays
• • A—HUMAN NECESSITIES
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  • A61B5/74—Details of notification to user or communication with user or patient; User input means
  • A61B5/746—Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms
• • A—HUMAN NECESSITIES
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  • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
  • A61B2562/22—Arrangements of medical sensors with cables or leads; Connectors or couplings specifically adapted for medical sensors
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
  • A61B2562/22—Arrangements of medical sensors with cables or leads; Connectors or couplings specifically adapted for medical sensors
  • A61B2562/221—Arrangements of sensors with cables or leads, e.g. cable harnesses
  • A61B2562/222—Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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  • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
  • A61B2562/22—Arrangements of medical sensors with cables or leads; Connectors or couplings specifically adapted for medical sensors
  • A61B2562/225—Connectors or couplings
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
  • A61B2562/22—Arrangements of medical sensors with cables or leads; Connectors or couplings specifically adapted for medical sensors
  • A61B2562/225—Connectors or couplings
  • A61B2562/227—Sensors with electrical connectors
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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  • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
  • A61B2562/22—Arrangements of medical sensors with cables or leads; Connectors or couplings specifically adapted for medical sensors
  • A61B2562/225—Connectors or couplings
  • A61B2562/228—Sensors with optical connectors
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
  • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
  • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
  • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
  • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
  • A61B5/14557—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases specially adapted to extracorporeal circuits
• • H—ELECTRICITY
  • H01—ELECTRIC ELEMENTS
  • H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
  • H01R13/00—Details of coupling devices of the kinds covered by groups H01R12/70 or H01R24/00 - H01R33/00
  • H01R13/46—Bases; Cases
  • H01R13/52—Dustproof, splashproof, drip-proof, waterproof, or flameproof cases
  • H01R13/5224—Dustproof, splashproof, drip-proof, waterproof, or flameproof cases for medical use
• • H—ELECTRICITY
  • H01—ELECTRIC ELEMENTS
  • H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
  • H01R2201/00—Connectors or connections adapted for particular applications
  • H01R2201/12—Connectors or connections adapted for particular applications for medicine and surgery

Definitions

• the present disclosure relates to the field of optical based physiological sensors.
• Regional oximetry also referred to as tissue oximetry and cerebral oximetry, enables the continuous assessment of the oxygenation of tissue. The measurement is taken by placing one or more sensors on a patient, frequently on the patient's left and right forehead. Regional oximetry estimates regional tissue oxygenation by transcutaneous measurement of areas that are vulnerable to changes in oxygen supply and demand. Regional oximetry exploits the ability of light to penetrate tissue and determine hemoglobin oxygenation according to the amount of light absorbed by hemoglobin.
• Regional oximetry differs from pulse oximetry in that tissue sampling represents primarily (70-75%) venous, and less (20-25%) arterial blood.
• the technique uses two photo-detectors with each light source, thereby allowing selective sampling of tissue beyond a specified depth beneath the skin. Near-field photo-detection is subtracted from far-field photo-detection to provide selective tissue oxygenation measurement beyond a pre-defined depth.
• regional oximetry monitoring does not depend uponactuatile flow.
• Regional oximetry is a useful patient monitoring technique to alert clinicians to dangerous clinical conditions. Changes in regional oximetry have been shown to occur in the absence of changes in arterial saturation or systemic hemodynamic parameters.
• the present disclosure provides a regional oximetry sensor.
• the regional oximetry sensor includes, for example, a face tape layer and a base tape layer adhesively attachable to a patient skin surface.
• the regional oximetry sensor also includes at least one emitter configured to transmit optical radiation into the patient skin surface, a near-field detector configured to detect the optical radiation after attenuation by tissue of the patient and a far field detector also configured to detect the optical radiation after attenuation by tissue of the patient, in an embodiment, the regional oximetry sensor also includes one or more focus elements associated with one or more of the emitter, the near-field detector and the far field detector, in an embodiment any or ail of the emitter, near-field detector and far field detector can be provided with a focus element.
• the focus element improves optical transmissions by gently pushing into the skin and providing improved optical coupling with the skin.
• the focus element can include a half-dome shape or any three dimensional shape that gently pushes into the skin to improve optical coupling.
• the focus element can also have a rectangular planar base in order to provide a support structure for cooperating with the face tape layer and/or other portions of the regional oximetry sensor.
• the focus element associated with the near-field detector is smaller than the focus element associated with the far field detector.
• the near field detector includes a square shape whereas the far field detector includes a larger rectangular shape.
• the regional oximetry sensor can have a face tape layer and a base tape layer adhesively attachable to a patient skin surface as discussed above.
• the sensor can also have at least one emitter configured to transmit optical radiation into the patient skin surface, a near-field detector configured to detect the optical radiation after attenuation by tissue of the patient, and a far field detector also configured to detect the optical radiation after attenuation by tissue of the patient, in some embodiments, the face tape layer and the base tape layer include a plurality of notches forming a plurality of cutouts.
• the plurality of cutouts can be formed in a portion of a periphery or across the entire periphery of the base and face tape layers, for example.
• the cutouts are mechanically decoupled from each other. Due to the mechanical decoupling, the cutouts allow for greater ease of patient movement of the measurement site. This reduces patient discomfort while wearing the regional sensor.
• a peei-off resistant regional oximetry sensor includes a head attachable to a patient skin surface and configured to transmit optical radiation into the skin and receive that optical radiation after attenuation by blood flow within the skin and a stem extending from the sensor head and configured to transmit electrical signals between the sensor head and an attached cable.
• the stem is terminated interior to the sensor head and away from an edge of the sensor head so as to define feet along either side of the stem distal the stem termination.
• FIG. 1 is a depiction of a patient monitoring system including regional oximetry sensors and a processing and display unit.
• FIGS. 2A-C are top and bottom perspective views and a connector-end view, respectively, of a regional oximetry sensor
• FIGS. 3A-C are top exploded, bottom partially-exploded and bottom assembled perspective views, respectively, of regional oximetry sensor head, stem and shell assemblies;
• FIGS. 4 is a bottom plan view a sensor cable and sensor flex circuit interconnection
• FIGS. 5A-H are a top plan view, top and bottom perspective views, first side and first side cross-sectiona! views, second side and second side cross-sectional views and a bottom view, respectively, of a near-field detector lens;
• FIGS, 6A-H are a top plan view, top and bottom perspective views, first side and first side cross-sectional views, second side and second side cross-sectional views and a bottom view, respectively, of a far-field detector lens;
• FIG. 7 is a cross-sectional view of a regional oximetry sensor attached to a tissue site and corresponding near-field and far-field emitter-to- detector optical paths;
• FIGS. 8A-B are a regional oximetiy monitor display of sensor placement options for an adult and a child, respectively.
• FIG. 8C is an exemplar regional oximetry monitor display using two regional sensors.
• FIGS. 9A-B are top perspective views of a regional oximetry sensor being inadvertently peeled from a skin-surface monitoring-site due to a pulling force applied to the sensor stem and interconnecting sensor cable;
• FIG. 10 is a top perspective view of a peel-off resistant regional oximetry sensor
• FIGS. 1 1A-B are top perspective views of a peel-off resistant regional oximetry sensor adhering to a skin-surface monitoring site despite a pulling force applied to the sensor stem and interconnecting sensor cable;
• FIGS. 12A, 12B, 13A and 13B are side-by-side, top perspective views of a regional oximetry sensor and a peel-off resistant regional oximetiy sensor subjected to like pulling forces and the corresponding impact of anti-peel feet extending from the cable-side of the peel-off resistant regional oximetry sensor.
• FIG. 1 is a physiological monitoring system 100 configured to measure and display regional oximetry measurements.
• the physiological monitoring system 100 includes at least a display 103 and a processor (not shown) for processing and displaying physiological measurements.
• the physiological monitoring system 100 also includes at least one sensor 200 for detecting physiological information and providing that physiological information to the processor of the physiological monitoring system 100.
• the physiological monitoring system includes a removable hand held physiological monitor 105.
• the physiological monitoring system 100 of FIG. 1 also includes a sensor cable system 106 that includes wiring 107 and a sensor connector 109.
• Sensor connector 109 includes ports for two or more sensors. The sensors are described in more detail with respect to FIGS 2A-2C.
• FIGS. 2A-C illustrate a regional oximetry sensor 200 embodiment having a sensor head 210, stem 220, shell 230, cable 240 and connector 250.
• the sensor head 210 houses an emitter 282, a near-field detector 284 and a far-field detector 288 within a layered tape having a top side 21 1 and an adhesive bottom side 212 disposed on a release liner 280.
• the release liner 260 is removed so as to adhere the bottom side 212 to a skin surface.
• the sensor head 210 also includes notches or channels 291 that form cutouts 293.
• the cutouts 293 are independently flexible from other neighboring cutouts.
• the cutouts 293 allow the sensor head 210 to be relatively large to increase the measurement area and adhesive surface area without greatly inhibiting patient movement.
• the sensor allows for some movement of the underlying skin so that the patient is more comfortable, yet provide a large enough surface area to provide good measurement and adhesive qualities.
• the regional oximetry sensor 200 is substantially fiat, allowing the sensor to adhere to the patient without significant bulges.
• the stem 220 extends out radially outward from the sensor head 210.
• the stem is positioned to extend from a radial edge in order to provide a clean exit from the body for wiring and cables.
• the radial placement also provides for streamlined sensor construction and prevents unnecessary bending or wrapping of internal or external wires.
• the emitter 282 and detectors 284, 288 have a lens that protrudes from the bottom side 212, advantageously providing a robust optics- skin interface.
• the top side 21 1 has emitter/detector indicators 272-278 so as to aid precise sensor placement on a patient site.
• the shell 230 houses the stem 220 to cable 240 interconnect, described in detail with respect to FIGS. 3A-C, below.
• the connector 250 is a 12 ⁇ pin, D-shaped plug.
• FIGS. 3A-C illustrate an assembly of a regional oximetry sensor portion including a head assembly (FIG. 3A) and a sensor cable to flex circuit interconnect (FIGS. 3B-C).
• a sensor head assembly 301 has a face tape 310, a flex circuit 320, a sensor cable 330, a stem tape 340, a base tape 350, a shell top 360 and a shell base 370.
• the face tape 310 and base tape 350 encase the flex circuit 320 and corresponding emitter and detectors.
• the shell top and base 360, 370 encase the sensor cable 330 to flex circuit 320 interconnect, described in further detail with respect to FIGS. 4A-B, below.
• the stem tape 340 encases the flex circuit 320 beiow the base tape 350.
• FIG. 4 illustrates sensor flex circuit 320 to sensor cable 330 interconnection.
• the flex circuit 320 is positioned on mounting pins in the top shell 360 (FIG. 3B).
• cable 330 wires are soldered to flex circuit pads 410, 420.
• Cable 330 Keviar bundles are wrapped around a shell post 430 for strain relief and secured with adhesive.
• a detector shield flap 440 is folded over detector wires soldered to the detector pads 410 and secured with Kapton tape.
• the base shell 370 (FIG. 3B) is then glued in place over the top shell 360 (FIG. 3B).
• FIG. 3B In the embodiment of FIG.
• the connections to the flex circuit 320 include four emitter anode conductors controlling four different wavelength emitters, a common emitter cathode conductor and an emitter shield, two near-field detector conductors, two far-field detector conductors and a detector shield.
• the emitter and detector connections are physically separated between different circuit pads, for example, pads 410 and 420. This reduces and/or prevents cross talk and noise between the emitter lines and the detector lines.
• pads 410 and 420 This reduces and/or prevents cross talk and noise between the emitter lines and the detector lines.
• FIGS. 5A-H illustrate an emitter lens and a near-field detector lens 500 having a generally half-dome focus element 501 and a generally rectangular, planar base 502.
• the lens base 502 is disposed over the flex-circuit-mounted emitter and near-field detector in order to focus emitted and detected light.
• the lens focus element 501 is configured to gently press into a tissue site when applied to the patient in order to maximize optical transmission via the skin surface.
• the focus elements can also use different three dimensional shapes as well in order to improve optical coupling with the skin and the present disclosure is not limited to the specific embodiments disclosed herein.
• the lens can be spherical, cubed, rectangular, square, circular oblong or any other shape to increase optical transmission with the skin.
• FIGS. 8A-H illustrate a far-field detector lens 600 having a generally oblong, half-dome focus element 601 and a generally oblong, planar base 602.
• the lens base 602 is disposed over the flex- circuit-mounted far-field detector so as focus detector received light.
• the lens focus element 601 gently presses into a tissue site in order to maximize optical transmission via the skin surface.
• the present disclosure is not limited to the specific dimensions and shape described herein which are provided for illustrative purposes. Rather, as discussed above, the present disclose extends to other shapes and sizes of a focus element that will improve optical coupling.
• the focus element 601 can comprise two or more different focus elements instead of a single larger focus element.
• FIG. 7 illustrates a regional oximetry sensor 700 attached to a tissue site 70 so as to generate near-field 760 and far-field 770 emitter-to- detector optical paths through the tissue site 70.
• the resulting detector signals are processed so as to calculate and display oxygen saturation (Sp02), delta oxygen saturation (ASpC ⁇ ) and regional oxygen saturation (rSC ⁇ ), as shown in FIG. 8C, below.
• the regional oximetry sensor 700 has a flex circuit layer 710, a tape layer 720, an emitter 730, a near-field detector 740 and a far-field detector 750.
• the emitter 730 and detectors 740, 750 are mechanically and electrically connected to the flex circuit 710.
• the tape layer 720 is disposed over and adheres to the flex circuit 710. Further, the tape layer 720 attaches the sensor 700 to the skin 70 surface.
• the emitter 730 has a substrate 732 mechanically and electrically connected to the flex circuit 710 and a lens 734 that extends from the tape layer 720.
• each detector 740, 750 has a substrate 742, 752 and each has a lens 744, 754 that extends from the tape layer.
• the lenses 734, 744, 754 press against the skin 70, advantageously increasing the optical transmission and reception of the emitter 730 and detectors 740, 750 through improved optical coupling.
• the lenses press into the skin and provide a more direct angle of light propagation through the skin between the emitter and detectors.
• FIGS. 8A-B illustrate regional oximetry monitor embodiments for designating adult and child sensor placement sites.
• an adult form 801 is generated on a user interface display.
• sensor sites can be designated on the adult form 801 , including left and right forehead 810, forearm 820, chest 830, upper leg 840, upper calf 850 and calf 860 sites.
• sensors 200 FIGGS. 2A-C
• a monitor in communication with these sensors then displays between one and four corresponding regional oximetry graphs and readouts, as described with respect to FIG. 8C, below.
• the senor can be positioned on a patient so that the sensor stem 220 and attached cabling can extend radially out from the body on the various regional oximetry sensor sites.
• This configuration reduces patient discomfort by preventing wiring from crossing or crisscrossing over a patient face, torso or lower body.
• This configuration also reduces the potential for entanglement of wires from the multiple sensors and associated cabling.
• a child form 802 is generated on a user interface display. Between one and four sensor sites can be designated on the child form 802, including left and right forehead 810, left and right renal 870, and left and right abdomen 880 sites. Any number of regional oximetry sensors can be deployed on a patient at the same time, but generally, between one and four sensors 200 (FIGS. 2A-C) are located on these sites at a given time. A monitor in communication with these sensors then displays between a corresponding regional oximetry graphs and readouts for each sensor, as described with respect to FIG. 8C, below. The displays of FIGS. 8A and 8B can also be selectively shown such that, for example, only an upper torso portion of the graphic is shown to prevent confusion by a care provider.
• FIG. 8C illustrates a regional oximetry display 800 embodiment for monitoring parameters derived from between one and four regional oximetry sensors 200 (FIGS. 2A-C).
• This particular example is a two sensor display for monitoring, for example, a forehead left 81 1 site and a forehead right 831 site.
• the forehead left 812 site displays, for example, an SpG 2 graph 812, an rS0 2 graph 814 and an rS0 2 readout 818.
• the forehead right 831 site displays, for example, an 8p0 2 graph 832, an rS0 2 graph 834 and an rSO? readout 838.
• the forehead left 851 site displays, for example, an SpG 2 readout 852, a ⁇ 80 2 readout 854 and a Abase readout 856.
• the forehead right 830 site displays, for example, an Sp0 2 readout 872, a ⁇ 80 2 readout 874 and a Abase readout 876.
• FIGS. 9A-B illustrate a problem that arises with a regional oximetry sensor 200 during use.
• the connector 250 is fixedly connected to a physiological monitor (not shown) that provides a read-out of parameters derived from the sensor 200.
• Patient movement away from the monitor may occur in a manner that pulls on the cable (not shown) and bends the attached stem 220 up and/or over the sensor head 210 (FIG. 9A).
• Continued patient movement away from the monitor may cause a portion of the sensor head 901 to peel off of the patient's skin (FIG. 2B), disrupting accurate parameter measurements. Indeed, continued patient movement may completely dislodge the sensor head 210 from the patient.
• a peel-off resistant regional oximetry sensor has a sensor head attachable to a patient skin surface so as to transmit optical radiation into the skin and receive that optical radiation after attenuation by blood flow within the skin.
• a stem extending from the sensor head transmits electrical signals between the sensor head and an attached cable.
• the stem is terminated interior to the sensor head and away from a sensor head edge so as to define feet along either side of the stem distai the stem termination.
• the stem interior termination substantially transforming a peei load on a sensor head adhesive to less challenging tension and shear loads on the sensor head adhesive.
• FIG. 10 illustrates an advantageous peel-off resistant regional oximetry sensor 1000 embodiment having a sensor head 1010, stem 1020, shell 230, cable 240 and connector 250.
• the sensor head 1010 houses an emitter, a near-field detector and a far-field detector within a layered tape having a top side and an adhesive bottom side disposed on a release liner, similar to that described with respect to FIGS 2A-B, above.
• the peel-off resistant regional oximetry sensor 1000 has peel-resistant feet 1012 proximately disposed on either side of the stem. The feet are defined by stem slots 1014 separating the feet from the stem. This configuration advantageously moves the stem 1020 base from the edge of the sensor head (e.g. 210 FIG. 2A) to the interior of the sensor head 1010. As a result, potential peel loads on the sensor head adhesive resulting from the stem 1020 being pulled over the sensor head are substantially reduced, as described with respect to FIGS. 12A-13B, below.
• FIGS. 1 1A-B illustrate a peel-off resistant regional oximetry sensor 1000 adhering to a skin-surface monitoring site despite a pulling force applied to the sensor stem 1020 and interconnecting sensor cable.
• Patient movement relative to connected monitor tends to cause the stem 1020 to peei up the sensor head (see FIG. 2B, above).
• the sensor head feet 1012 advantageously extend away from the point where the stem 1020 begins applying a load to the sensor head adhesive, thus counteracting the peel away force.
• the resulting adhesive loads are different in kind and magnitude than the adhesive loads on the sensor head shown and described with respect to FIG. 2, above. Comparative adhesive loads are described in detail with respect to FIGS. 12A-13B, below.
• FIGS. 12A-13B illustrate comparative adhesive loads applied to a regional oximetry sensor and a peel-off resistant regional oximetry sensor resulting from cable forces applied to the sensor head stems 220 (FIGS. 12A-B), 1020 (FIGS. 13A-B).
• the stem 220 applies a substantial peel load 221 to the sensor head 210 adhesive 222, and the peel load 221 is distributed over a relatively small area 223 of the sensor head 210.
• a peel load 221 is a substantial challenge to any adhesive, and the milder adhesives used on skin cannot easily overcome this challenge. As such, it is relatively easy for the sensor head 210 to become dislodged or completely detached from the patient.
• the cumulative effect of positioning the stem 1020 somewhat to the interior of the sensor head 1010 and behind the feet 1021 is a greatly diminished adhesive peel load and much less challenging shear and tension loads distributed over a larger adhesive footprint.
• the advantageous result is a sensor head-to-cable stem interface that is much less likely to dislodge the sensor head from the patient when forces are applied to the sensor cable.
• more skin-friendly adhesives can be utilized for sensor head attachment as a result of lowered adhesive loads.
• a peel-off resistant regional oximetry sensor has been disclosed in detail in connection with various embodiments. These embodiments are disclosed by way of examples only and are not to limit the scope of this disclosure or the claims that follow. One of ordinary skill in art will appreciate many variations and modifications.
• Conditional language used herein such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or states. Thus, such conditional language is not generally intended to imply that features, elements and/or states are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or states are included or are to be performed in any particular embodiment.
• acts, events, or functions of any of the methods described herein can be performed in a different sequence, can be added, merged, or left out altogether (e.g., not all described acts or events are necessary for the practice of the method).
• acts or events can be performed concurrently, e.g., through multi-threaded processing, interrupt processing, or multiple processors or processor cores, rather than sequentially.
• DSP digital signal processor
• ASIC application specific integrated circuit
• FPGA field programmable gate array
• a general purpose processor can be a microprocessor, but in the alternative, the processor can be any conventional processor, controller, microcontroller, or state machine.
• a processor can also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.
• a software module can reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, a hard disk, a removable disk, a CD-ROM, or any other form of computer-readable storage medium known in the art.
• An exemplary storage medium is coupled to a processor such that the processor can read information from, and write information to, the storage medium.
• the storage medium can be integral to the processor.
• the processor and the storage medium can reside in an ASIC.
• the ASIC can reside in a user terminal.
• the processor and the storage medium can reside as discrete components in a user terminal.

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